Treatment of High-risk Newly Diagnosed Multiple Myeloma With Minimal Residual Disease Detection

PHASE4RecruitingINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

June 12, 2024

Primary Completion Date

November 30, 2027

Study Completion Date

December 31, 2027

Conditions
Newly DiagnosedHigh RiskMRDMultiple Myeloma
Interventions
DRUG

Carfilzomib

"Induction:~ASCT:20mg/56mg/m2 ,D1,8,15,C2-4; non ASCT: 20mg/36mg/m2 ,D1,8,15,C2-4;~Consolidation:~ASCT: 56mg/m2 ,D1,8,15,C5-6; non ASCT: 36mg/m2 ,D1,8,15,C5-8;~Maintenance:~ASCT: 70mg/m2 ,D1,15; non-ASCT:56mg/m2 ,D1,15 After consolidation therapy, if MRD negativity is sustained for more than 1 year, carfilzomib will be discontinued"

DRUG

Daratumumab

"28d/Cycle~Induction:~16mg/kg, D1,8,15,22,C 2-3,16mg/kg, D1,15, C4;~Consolidation:~ASCT: 16mg/kg/d, D1,15,C5-6; non ASCT: 16mg/kg/d, D1,15,C5-8;~Maintenance:~16mg/kg, D1,monthly After consolidation therapy, if MRD negativity is sustained for more than 1 year, daratumumab will be discontinued"

DRUG

Lenalidomide

"28d/Cycle~Induction:~25mg qd d1-21 C2-C4;~Consolidation:~ASCT: 10mg d1-21,C5-6; non ASCT: 25 mg d1-21,C5-8;~Maintenance: 10mgqd D1-21~After consolidation therapy, if MRD negativity is sustained for more than 1 year, lenalidomide monotherapy will be maintained until disease progression"

DRUG

Dexamethasone

"28d/Cycle~Induction:~ASCT:40mg qd, po/iv,D1,8,15,22,C2-4; non ASCT:20mg qd, po/iv,D1,8,15,22,C2-4;~Consolidation:~ASCT: 40mg qd, po/iv,D1,8,15,22,C5-6; non ASCT:20mg qd, po/iv,D1,8,15,22,C5-8"

DRUG

VRD for first-cycle induction therapy

"Induction:~C1, 28d/cycle Bortezomib(V):1.3 mg/m2,H,d1、4、8、11; Lenalidomide(R):25mg,po. qd d1-14; Dexamethasone(D):20 mg,po/iv,D1,2, 4,5, 8,9, 11,12。"

Trial Locations (1)

215000

RECRUITING

The First Affiliated Hospital of Soochow University, Suzhou

All Listed Sponsors
lead

The First Affiliated Hospital of Soochow University

OTHER